SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with a sterility defect. Lack of sterility assurance in intravenous medications poses a significant risk of serious infection and harm to patients, meeting the rubric criterion for Severe (Class II with risk of significant injury).
Plain-English summary
SterRx, LLC is recalling Norepinephrine in 5% Dextrose Injection, 8 mg per 250 mL (32 mg/mL), NDC 70324-476-01, lot code S21409/CCR. The recall affects 1,428 bags distributed nationwide in the United States.
The recall was initiated due to lack of assurance of sterility. This product is a prescription-only injectable medication used in hospital and clinical settings.
Patients and healthcare providers who have received or are currently using this product should contact their healthcare provider or pharmacy for guidance. The FDA classifies this as a Class II recall.
The recalled product
- Product
- NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 1,428
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S21409/CCR
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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